Evaluation and EUA validation of a production ready portable, Point-of-Need Platform for detection of COVID-19 direct from nasal swabs in 30 minutes.

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BG Research have a simplified method for testing patients for infections caused by viruses, the QuRapID-XF technology. Developed in response to the Ebola outbreak, it enables portable testing directly from patient samples. This removes the need for a lab or expert users -- important as it was designed to be used in resource poor environments in rural Africa.This project will generate a direct from nasal swab test for COVID-19 infections that could be used anywhere, for example at ports of entry or via first responder. At-Point-Testing (APT) will be vital to effectively deal with COVID-19 in the UK. This approach is a highly sensitive, portable platform that ensures infected and those with no symptoms but infected(early stage) patients can be rapidly identified and isolated . . The portable molecular testing system can be used anywhere and gives results within 30 minutes while the patient waits . Hence facilitating immediate isolation and contact tracing.This COVID-19 test will work directly from nasal swabs, but the technology detects directly from saliva, blood, urine or other crude samples. QuRapID-XF assays are simple, so can be performed by non-expert personnel such as soldiers and nurses and large numbers of while-you-wait tests could be performed. Antigen tests based on molecular diagnostics are many times more sensitive than lateral flow tests, immunological tests, and can be used to differentiate between different viral diseases causing e.g. respiratory symptoms, such as the flu.This project will see the scaled release of this platform technology.PHE will be able to deploy their own assays onto the platform to rapidly respond to future outbreaks of blood borne and respiratory viral diseases. QuRapID-XF can also bring low cost testing to poorer developing nations.As the approach doesn't require nucleic acid extraction and uses our own reagent and instrument, there will be none of the supply chain issues seen relating to testing and so it will be possible to deliver large numbers of tests rapidly in response to any future outbreaks.The assay will go through a performance evaluation at multiple sites and countries, ensuring that the test will be highly sensitive. This technology allows the UK to respond to biosecurity threats, and outbreaks of human or veterinary viral diseases globally, reducing mortality and economic losses caused by disease.